Events

Rappel de Device Recall HerpeSelect 1 and 2 Immunoblot IgG Kit

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Focus Diagnostics Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    47459
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1764-2008
  • Date de mise en oeuvre de l'événement
    2007-07-06
  • Date de publication de l'événement
    2008-08-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-06-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69534
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Enzyme Linked Immunoabsorbent Assay - Product Code LGC
  • Cause
    A small percentage of samples tested in specific lots, the hsv common antigen band appears lighter (less reactive) than the reading control band. reduced reactivity of the common antigen band may lead to inaccurate interpretation of a sample as negative.
  • Action
    Focus notified all clients which received the recalled lots starting on July 6, 2007 via an Important Medical Device Information letter by fax or email. The letter explains how to identify suspect results and the steps to be taken if suspect results are obtained. If customers find the interpretation of results with the indicated kit lots to be problematic, customers have the option of having their kits replaced at no charge within 90 days of receiving the notification.

Device

Device Recall HerpeSelect 1 and 2 Immunoblot IgG Kit
  • Modèle / numéro de série
    Lot Codes 063169 (Expires December 2007), 063354 (Expires October 2007), 063355 (Expires July 2007)
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- USA including states of OH, CA, CT, IL, NY, and countries of Barbados, Canada, Germany, Israel, Slovakia, France, and England.
  • Description du dispositif
    HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G || Intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 and HSV-2 in human sera.
  • Manufacturer
    Focus Diagnostics Inc

Manufacturer

Focus Diagnostics Inc
  • Adresse du fabricant
    Focus Diagnostics Inc, 10703 Progress Way, Cypress CA 90630-4714
  • Source
    USFDA